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Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860897
Recruitment Status : Withdrawn (Unable to provide study medications due to cost.)
First Posted : August 9, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Andrey Petrikovets, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 9, 2016
Last Update Posted Date May 2, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
Time in days to discontinuation of vagifem tablet or premarin cream. [ Time Frame: 6 weeks ]
Days upon which patients stopped using vagifem tablets or premarin cream
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
  • Pelvic floor disease inventory-20 [ Time Frame: preoperatively, 2 weeks, 6 weeks. ]
    The investigators will use the pelvic floor disease inventory-20 survey and compare its results preoperatively, 2 weeks and 6 weeks after surgery.
  • Postoperative complications [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery
Official Title  ICMJE Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery
Brief Summary

PURPOSE: To evaluate patient adherence to cream versus tablet based local estrogen therapy by randomizing treatment modalities to determine differences in adherence to either form.

HYPOTHESIS: There is no difference in adherence to cream versus tablet based local estrogen therapy when prescribed as a 6 week course of postoperative therapy after female pelvic reconstructive surgery.

Detailed Description

Genitourinary syndrome is the consequence of the lack of estrogen exposure to the genitourinary tract during menopause. The result of this hypoestrogenic state is the thinning, shrinking, increased vaginal friction, and increase in lower urinary tract symptoms. It is estimated that up to 60% of postmenopausal women experience these symptoms and the widely accepted treatment for genitourinary syndrome is the application of local estrogen.

Estrogen has been widely prescribed as a beneficial adjunct in the treatment of menopausal genitourinary syndrome and is used to decrease the incidence of urgency, frequency, nocturia, stress urinary incontinence, urge urinary incontinence, and recurrent urinary tract infections. Despite the well described use of local estrogen therapy for genitourinary syndrome, not all forms of vaginal estrogen are created equally and patient adherence to prescriptions has not been uniform among different formulations. Shulman and colleagues noted that when used for genitourinary syndrome, patients who were prescribed local estrogen tablets demonstrated significantly longer compliance to therapy than those prescribed estrogen cream (149 days vs. 92 days). Similarly, in a cohort of 30,000 patients, Portman demonstrated that patients prescribed vaginal estrogen tablets were also more likely to be adherent to therapy than those given the cream formulation. Some of the reasons for early discontinuation of local vaginal cream was due to messiness with application, leakage, concerns about underdosing or overdosing, and that the cream was generally unpleasant.

Given the extensive use of local estrogen for genitourinary syndrome, despite limited data, surgeons have been prescribing local estrogen to prevent the development of postoperative complications like lower urinary tract symptoms after female pelvic reconstructive surgery. In a postoperative 12 week follow up, Karp and colleagues noted that the administration of a vaginal estrogen tablets in postmenopausal women is associated with improved vaginal maturation indices and objective atrophy assessment after vaginal reconstructive surgery. Vaccaro also noted that preoperative administration of vaginal estrogen administered 2- 12 weeks before reconstructive surgery improves the vaginal maturation index by more than 15.5% and may improve the tissue as a substrate for suture placement. There have been two studies evaluating the effect of vaginal estrogen after midureteral sling placement: Zullo studied retropubic midureteral slings and noted that patients who did not receive vaginal estrogen tablets exhibited a higher incidence of urinary urgency than patients who did (4% vs. 29%). Liapias evaluated local estrogen application for 6 months after transobturator tape slings and noted statistically significant decreases in urinary frequently and urgency.

Given this data, there appears to be a role for postoperative local estrogen therapy after pelvic reconstructive surgery but it not clear if patients are adherent to therapy and the form of therapy: cream or tablet. To the best of the investigators knowledge, there is no data that describes patient adherence to local estrogen therapy after female pelvic surgery. Therefore, the purpose of this study is to evaluate patient adherence to cream versus tablet based local estrogen therapy by randomizing treatment modalities to determine differences in adherence to either form.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Estrogen
  • Menopause
  • Pelvic Floor Disorders
  • Surgery
Intervention  ICMJE
  • Drug: Premarin
    Vaginal estrogen cream
  • Drug: Vagifem
    Vaginal estrogen tablet
Study Arms  ICMJE
  • Experimental: Vaginal estrogen cream
    Intervention: Drug: Premarin
  • Experimental: Vaginal estrogen tablet
    Intervention: Drug: Vagifem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2016)
96
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who underwent female pelvic reconstructive surgery at University Hospitals Case Medical Center and were given postoperative local estrogen therapy.
  • Patients who consented to the study.
  • Postmenopausal

Exclusion Criteria:

  • Patients who were not given a prescription for postoperative lower estrogen therapy despite undergoing surgery.
  • Patients with contraindications to vaginal estrogen.
  • Any obliterative procedures. Patients who are unable to participate in informed consent. Patients younger than 18. Non English speaking patients
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02860897
Other Study ID Numbers  ICMJE 08-15-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrey Petrikovets, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospitals Cleveland Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP